Anti Xa Levels Under Two Different Regimens of Enoxaparin VTE Prophylaxis After Sleeve Gastrectomy for Morbid Obesity

NCT01970202 | Unknown Phase 4

• 1 other identifier: TASMC-13-GL-0241-CTIL
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately two thirds of the adult population in developed countries is categorized as over-weight or obese (BMI\>30). In spite of worldwide increasing awareness, obesity is a major health concern. In the presence of numerous diets, medical therapies, and robust research, bariatric surgery remains the most effective means of weight reduction in morbidly obese patients (BMI\>40, or BMI\>35 with co-morbidities). However, bariatric surgery harbors a relatively high risk for postoperative complications; of them, venous thromboembolic events (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly obese patients to develop VTE, perioperative thromboprophylaxis is mandatory. To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in the aforementioned population. Due to the pharmacologic properties of LMWH and the characteristics of surgically treated obese patients, the optimal dose that is to be utilized for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa levels in the patients' plasma can be used in order to monitor LMWH activity. Levels of 0.2-0.5 U/ml have been proposed by some authors for VTE prophylaxis. Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h) for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were small non- randomized trials, containing numerous methodological weaknesses. Hence, the optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed population remains unclear. The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing two most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients undergoing bariatric surgery.

Conditions

Obesity

Keywords

obesity; overweight; sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• Anti-factor Xa plasma levels

  within 3 days after surgery

Study Arms (3)

40mg Enoxaparin

ACTIVE COMPARATOR

Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.

Drug: 40mg Enoxaparin

60mg Enoxaparin

ACTIVE COMPARATOR

Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.

Drug: 60mg Enoxaparin

Control

OTHER

no treatment

Other: Control

Interventions

40mg Enoxaparin DRUG

Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.

Also known as: clexane

40mg Enoxaparin

60mg Enoxaparin DRUG

Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.

Also known as: clexane

60mg Enoxaparin

Control OTHER

no treatment

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient undergoing laparoscopic sleeve gastrectomy.
• The patient undergoes the surgery in the surgical wing of the Tel-Aviv Sourasky Medical Center.
• The patient has received full information regarding the studies nature, has agreed to participate and has given informed consent (documented by a signed informed consent form).

You may not qualify if:

• Patients with a previous Venous Thromboembolic Event.
• Patients requiring an IVC filter.
• Patients with known thrombophilia due to coagulation factor disorders (i.e factor V leiden).
• Patients with a bleeding disorder
• Patients with renal failure.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky medical center

Tel Aviv, Israel

Location

Related Publications (1)

• Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.

  PMID: 36413425 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Guy Lahat, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Lahat, MD

CONTACT

972527360237; guyla@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 28, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: October 28, 2013

Record last verified: 2013-10

Locations

IL (1)